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After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11).

Drug: Neoadjuvant chemotherapy

four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,

Active Comparator: surgery

surgery

Procedure: surgery and Adjuvant chemotherapy

surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)

T1-3, Nx, M0 (UICC 6th version, 2002)

infiltration of the portal vein (<180°) is not an exclusion criterion

cytologic or histologic confirmation of adenocarcinoma

age >18 years

written informed consent

Exclusion Criteria:

contraindication for Whipple procedure

an infiltration >180° of the portal vein

abutment of the tumor to the superior mesenteric artery

infiltration of the superior mesenteric artery or the celiac trunk

chronic neuropathy > grade 2

WHO performance score >2

uncorrectable cholestasis (bilirubin > 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)